Development of an automated HIV self-testing assay

项目摘要 虽然抗逆转录病毒疗法（ART）在挽救艾滋病患者的生命方面是有效的，但ART的实施 由于缺乏治疗、监测、诊断和疾病控制， 管理根据美国艾滋病署最近的统计，尽管如此，抗逆转录病毒治疗的覆盖率仍然只有59%， 在大多数国家，抗逆转录病毒疗法是负担得起的或免费提供的。此外，在全球范围内，约有四分之一的人 感染病毒的人不知道自己的艾滋病毒状况。减少艾滋病毒的根本挑战之一 负担及其流行的一个主要原因是缺乏足够敏感的艾滋病毒自我检测方法， 在感染后的头两周（急性期）内新感染艾滋病毒， 目前的自我检测技术只能检测宿主抗体反应， HIV感染，通常在初次感染后3-4周出现，它不是治疗的指标 失败和病毒反弹。没有自我测试技术已经商业化，能够检测 艾滋病毒在急性感染的早期阶段或抗逆转录病毒治疗受抑制患者的病毒反弹。 为了获得艾滋病毒检测和改善治疗结果，迫切需要开发可靠和 负担得起的艾滋病毒自我检测技术。为了应对这些挑战，我们建议开发一种 自我检测HIV-1芯片，可以（i）从全血样本中选择性地检测HIV，（ii）高度敏感 在急性感染、治疗和病毒反弹期间检测艾滋病毒（<1000拷贝/毫升），（iii）迅速（在 40分钟），（iv）高度稳定（无需冷藏），以及（v）完全自动化（真正的样品应答- out）。

Project Summary Although antiretroviral therapy (ART) is effective in saving AIDS patients' lives, the implementation of ART worldwide has been drastically hampered by the lack of treatment monitoring diagnostics and disease management. According to the recent statistics by USAIDS, the coverage of ART is still only 59%, despite ART being affordable or freely available in most countries. In addition, worldwide, about 1 in 4 of the people that contracted the virus are unaware of their HIV status. One of the fundamental challenges to reduce HIV burden and its prevalence is the absence of HIV self-testing assays which are sensitive enough to detect new HIV infections during the first two-weeks (acute phase) post-infection and viral rebound in virally supressed patients receiving ART. Current self-testing technologies only detect the host antibody response to HIV infection, which usually arises 3-4 weeks after the initial infection and it is not an indicator of therapy failure and viral rebound. No self-testing technologies have yet been commercialized that are able to detect HIV during the early stages of acute infection or viral rebound in suppressed patients on ART. To increase access to HIV testing and to improve treatment outcomes, there is an urgent need to develop reliable and affordable HIV self-testing technologies. To address these challenges, we propose to develop a disposable self-testing HIV-1 chip that can (i) selectively detect HIV from whole blood samples, (ii) be highly sensitive to detect HIV during the acute infection, treatment and viral rebound (<1000 copies/ml), (iii) be rapid (within 40 minutes), (iv) be highly stable (refrigeration-free), and (v) be fully automated (true sample-in-answer- out).